Self-Guided Resilience-Building Energy Management to Enhance Well-being Intervention for People With Systemic Sclerosis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Feasibility based on study retention
研究概览
简要总结
The goal of this clinical trial is to gather information on the RENEW app used by people with scleroderma. Specifically, the researchers want to learn more about RENEW by collecting information about the rates of recruitment, retention of study participants information about study completion, and time spent accessing the app content.
详细描述
RENEW is Institutional Review Board approved as a non-significant risk device but it not subject to 510(k) and therefore not regulated by the FDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of systemic sclerosis including: diffuse cutaneous SSc, limited cutaneous SSc, overlap, or SINE
- •Have access to a reliable, internet-connected device (e.g. smartphone or tablet)
- •Be able to read, speak, and understand English
- •Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions1
排除标准
- •Complex, unstable health issues that would preclude full participation in the study
- •Planning to start new treatment for fatigue, pain, mood during the study period
- •Previous experience with RENEW app or past participant of RENEW
研究组 & 干预措施
RENEW
Individuals with SSc who are interested and eligible will undergo an informed consent process and will be given access to the RENEW program via the app
干预措施: RENEW (Device)
结局指标
主要结局
Feasibility based on study retention
时间窗: 12 weeks
Number of participants who complete the study
Feasibility based on study recruitment rate
时间窗: 12 weeks
Number of participants enrolled (over 3 months) divided by the number of individuals who were eligible to participate
次要结局
- RENEW participation - website(12 weeks)
- Acceptability(12 weeks)
研究者
Susan Murphy
Title Professor of Physical Medicine and Rehabilitation, Research Professor, Institute of Gerontology and Professor of Internal Medicine
University of Michigan